P2P: Where Next?

There is one official final step in the P2P process: a federal partners meeting supposed to be held six to eight months after the workshop. But there are other marching orders, too. For us.

Federals Only

As described on the P2P website, there is a federal partners meeting six to eight months after each workshop. The purpose of the partners meeting is to review the panel’s report and identify possible opportunities for collaboration. The key here is that it is federal partners only – no other stakeholders are invited as far as I can tell.

Only one P2P workshop has progressed to the partners meeting. The Polycycstic Ovary Syndrome (PCOS) federal partners meeting was held in May 2014, almost 18 months after the PCOS workshop. There is no list of attendees posted online, but a basic summary of the meeting is available. A number of ideas seem to have been tossed around, but no specific action items or commitments were made by the federal partners.

The takeaway is that the final P2P step is a meeting for federals only, without a track record of producing actions or commitments. For all the fuss and promotion around P2P, NIH seems rather uninterested in applying anything that comes out of the process.

The To Do List

But WE don’t have to take the same attitude. As I said in my post about the P2P report’s failures, there are good things in the report too. I have compiled a list of all the action items suggested by the Panel, and I think we should use it to check NIH’s progress at every opportunity.

You can see the full list here. I’ve included citations to the pages where these recommendations appear. The only changes I made were to make the phrasing active, rather than passive. The recommendations are listed in the order with which they appear in the document. I had hoped the Panel would explicitly prioritize their recommendations, but the order remained unchanged from the draft report. It is a very long list of action items: sixty-five in total. What it boils down to is this:

Reach consensus among the stakeholders on a case definition.

Prioritize biomedical research for biomarkers, pathogenesis, diagnostics, prognostics, and therapeutics, including -omics and imaging studies.

Create a central repository/registry for biological samples and clinical data.

Increase patient involvement in creating research priorities, patient-reported outcomes, and the case definition.

Disseminate best practices and training to primary and specialty physicians.

Create a network of centers to determine: biomarkers for diagnosis and prognosis; epidemiology; outcomes; cost-effectiveness; co-morbidities; recovery; and control populations.

Convene an ME/CFS expert panel in five years to monitor progress.

Many of these items have been recommended by the CFS Advisory Committee and advocates many times before. This is a list that cannot be completed in five years, and which will never be completed without a very substantial increase in investment.

But a significant value of this list is that it gives us the structure for an NIH report card. We should, at every opportunity and in every possible venue, ask what progress is being made on the list. Print out that NIH report card and share the list with Congress, asking them to monitor NIH’s progress on this advice which, after all, NIH requested itself. Bring the list to every CFSAC and ask the NIH ex officio what progress is being made. Mark your calendar for June 2020, and demand that ODP reconvene an expert panel to monitor progress.

And if no progress is made? If NIH focuses on the cheap and easy recommendations? Then we wave this list and remind them that THEY requisitioned these recommendations, not us. These are not recommendations from the same crowd that has been making the same recommendations for twenty or thirty years.

Funding Funding Funding

Despite the Panel’s reluctance to explicitly recommend an increase in ME/CFS research funding, it is patently obvious that the necessary progress cannot be made on $5 million a year. We must continue our demands for increased NIH funding, especially because it looks like NIH might get a 6% increase in budget in FY2016. Much of those funds will go to “sexier” projects like precision medicine and the BRAIN initiative. But NIH cannot continue to claim there is simply no money.

If you can’t find a petition or one-click campaign that fits your views, then consider starting your own. ME Action provides a platform with organizing tools for a variety of actions. And it bears repeating that contacting your own representatives is always a good idea. Congress may especially be interested in whether HHS takes any of the expensive advice they got from IOM and P2P.

Marching Orders

Here’s the bottom line: the P2P Panel recommended research priorities that will cost a lot of money to carry out. Many of the recommendations match what advocates have been saying for years. The only way to make progress is to significantly increase research funding for ME/CFS.

NIH controlled the P2P process. NIH selected the panel members, defined the questions, designed the evidence review and the workshop agenda. This has been NIH’s game, played by their rules. If NIH does not like the advice they got, or if this was all just a show never intended to go anywhere, then that just gives us even more political ammunition.

We must demand the necessary increase in funding. We must hold NIH accountable to the report card of recommendations. We’ve got our work cut out for us.

Re: Item 6 – for a disease that is characterised by global Governmental disregard, Epidemiology is perhaps the most significant area of abject neglect. There really is no understanding anywhere in the developed world (let alone in poorer countries), of who is presenting with ME/CFS, the level of disablement they experience, the severity of illness or the pattern of disease progression. We have many cursory assumptions about the patient population(s) which are based on either poorly designed or inadequately focussed research, or upon the accumulated results of many small studies which lack adequate standardisation. The often stated certainties of the male to female ratio, the numbers severely ill, the age profile, socio-economic distribution etc, are based on often little more than confirmation bias from researchers, clinicians and patients.

Providing meaningful support to patients depends on interventions being appropriately targetted – the needs of 15 year old males may be radically different to that of 55 year old females. Sound, detailed epidemiological data is essential; the processes of epidemiology are well understood, there is no need for novel systems nor for extraordinary research proposals. Every country with an established system of health delivery and Govermental support for health research should be properly evaluating who has ME/CFS and how those patients are interacting with health and disability services. This is one area where patients could organise co-operatively across National boundaries and where the resulting data would unequivocally be of broad and continuing relevance.

I agree that epidemiology is fundamental, and it’s a disgrace that we don’t have good data already. This does lead us back to case definition, though. What is a true case? Should PEM be required? CDC’s multisite study is a potentially sound approach to epidemiology, BUT it’s a tertiary care population, mostly white, mostly women, mostly insured – which skews the data. And CDC has been pretty clear up until now that they do not believe PEM should be required. No word on where they stand re: SEID.

So yes, epidemiology is key. But we need to find a way past the “true case” dilemma so that everyone can start from the same place.

Jenny, I don’t believe case definition is an inhibition to epidemiological progress. Epidemiological studies are consistently faced with limitations produced by health disparities, cultural prejudices and a wide range of other conflicting and compounding factors. And even a perfect case definition will not address exclusion from health services by reason of poverty, lack of patient articulation or poor education. Short of mass population screening, patients presenting at such health services that there are, are the only concrete epidemiological evidence that is available.

A sound epidemiological approach would bracket the target illness by setting parameters of ill health that allow for variation in physician diagnosis such that a core symptomology would be defined and contrasted with all the outliers identified through the health services under examination. I understand people will be nervous about this approach because it may seem to mirror the disaster of the Empirical Criteria study, but the process should be very different. Rather than trying to define the disease as Reeves et al did by seeing what patient population they could capture, it would be a matter of identifying those patients seeking support from health services who were presenting with a spectrum of illness which centres around Fukada/CCC/SEID or whatever diagnostic base is deemed appropriate. Epidemiology is a major route to breaking the research log jam, a clear picture of the population that deems itself to be ill with ME/CFS type illness(es) will aid better understanding of the illness from all research perspectives and other than lack of finance there is no inhibition as to why this should not progress.

Thanks, Jennie – I particularly appreciate you distilling down a clear to do list out of 65 recommendations!

I agree with holding the NIH to a report card, and even more about the cash.

Here’s the bottom line: the P2P Panel recommended research priorities that will cost a lot of money to carry out. Many of the recommendations match what advocates have been saying for years. The only way to make progress is to significantly increase research funding for ME/CFS.

NIH controlled the P2P process. NIH selected the panel members, defined the questions, designed the evidence review and the workshop agenda. This has been NIH’s game, played by their rules. If NIH does not like the advice they got, or if this was all just a show never intended to go anywhere, then that just gives us even more political ammunition.

We must demand the necessary increase in funding.

I just wonder if we could use the NIH’s P2P report as the focus on an immediate campaign focusing on the NIH directly as well as via Congress – looking for a big gain to say $25m funding of mecfs next financial year – a downpayment on what’s necessary.

But then I know a lot of people would be put off by something that presents the p2p report as something to be followed. I just hate to see a good weapon like that left unfired.

I think it can be done, Simon. The price tag is a potential deal breaker on the fed side, but if NIH gets the projected increase in the budget that argument is harder to sell. There are definitely actions to take, and I hope to have more on that soon.